The FDA has granted de novo regulatory approval to Pelvalon (Sunnyvale, CA) for its Eclipse vaginal insert for treating fecal incontinence. The choice of orifice may be a bit surprising, but the device works by exerting pressure on the rectum through the vaginal wall, just where a tampon is typically positioned, effectively closing off the rectum. When a trip to the bathroom is needed, the device is deflated and then re-inflated using an external pump.
The Eclipse is intiially fitted and inflated by a trained clinician, following which the patient can control it herself. There has not been anything quite like this on the market before, and though awkward may prove to be a popular drug-free solution for women struggling with bowel control. Interestingly, urinary incontinence was noted as a side effect.
From the FDA:
The FDA reviewed data for the Eclipse System through the de novo classification process, a regulatory pathway for some low-to-moderate risk medical devices that are not substantially equivalent to a legally marketed device.
The FDA granted the de novo request based on non-clinical testing as well as a clinical trial of 61 women with FI treated with the device. The trial showed that after one month almost 80 percent of women in the study experienced a 50 percent decrease in the number of FI episodes while using the device, as compared to baseline.
Adverse events associated with the device included pelvic cramping and discomfort; pelvic pain; vaginal abrasion, redness, or discharge; and urinary incontinence. All device-related adverse events were mild or moderate, and none required any significant intervention (i.e., no surgeries were needed).
Study of the Eclipse in journal Obstetrics & Gynecology: A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence.
FDA: FDA permits marketing of fecal incontinence device for women
Pelvalon press release: FDA Approves Pelvalon’s Marketing Application for the Eclipse™ System, the First Vaginal Insert for Loss of Bowel Control